High Potency API (HPAPI) | Contract Manufacturing

Seqens is a contract development and manufacturing organization that offers highly potent and oncology APIs with OEB 4 and 5 (1µg/m3) levels. It is involved in the production of clinical and lab to full commercial scales of potent molecules.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

02

Minakem

France

Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

Pharma Service : API Manufacturing

Minakem offers state-of-the-art high containment manufacturing facility for highly potent APIs from early-stage development to scale-up and commercial manufacturing. It can handle HPAPIs with OEL below 0.1μg/m³/shift (OEB class 5).

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

03

Gentec Pharmaceutical Group

Spain

CPhI WW Frankfurt

Booth #11.1C90

Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.

Pharma Service : API Manufacturing

Gentec's Duke Chem and Pharmanoid plant offers manufacturing services for high potency active pharmaceutical ingredients (HPAPIs) and APIs under the contract manufacturing modality.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

04

TAPI Technology & API Services

Israel

TIDES USA

TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

Pharma Service : API Manufacturing

TAPI is a CDMO for high potent APIs (HPAPIs), supporting its R&D through commercial manufacturing with reactor sizes ranging from less than 100 liters to 7,000 liters.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

05

Egis Pharmaceuticals PLC

Hungary

PharmaVenue

Egis Pharmaceuticals has GMP production lines that can handle 1 g/m3 < OEL < 10 g/m3 (OEB4) levels of highly potent APIs. It also produces HPAPIs for formulation experiments, clinical trials, and commercial purposes with an annual capacity of ca. 600 kg.

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Pharma Service : API Manufacturing

HIGHLY POTENT API MANUFACTURING

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

06

Polpharma

Poland

Polpharma API is a contract development and manufacturing organization (CDMO) specializing in the manufacturing of high-potency APIs (HPAPIs) in its dedicated GMP kilo-labs, with an occupational exposure limit (OEL) as low as 10ng/m3 (OEB 6).

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

Pharma Service : API Manufacturing

HPAPI MANUFACTURING

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

07

Axplora

Germany

PMWS25

Axplora is your partner of choice for complex APIs.

Pharma Service : API Manufacturing

Axplora offers a full range of high-potency API (HPAPI) manufacturing services. It also has great expertise in the development, scale-up, and handling of cytotoxics and highly active compounds with an OEL below 10 ng/m³.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

08

AbbVie Contract Manufacturing

U.S.A

PMWS25

AbbVie CMO has the capability of producing HPAPI with containment capabilities up to OEB5 (<0.1 µg/m3). Its Campoverde and Sligo sites have over 20 years of experience and can support a broad range of commercial GMP batch sizes from gram scale to 600 kg.

AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

Pharma Service : API Manufacturing

MANUFACTURING OF HIGHLY POTENT APIs

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

09

Veranova

U.S.A

Booth #536

Veranova: A CDMO that manages complexity with confidence.

Pharma Service : API Manufacturing

With an increasing number of new drugs under development containing highly potent APIs (HPAPIs), Veranova is able to combine its extensive technical expertise with specialized equipment to produce HPAPIs (SafeBridge®4) with OEL as low as 1 μg/m3.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

Aspen API has expertise in manufacturing high potency APIs (HPAPIs) and cytotoxic APIs, produced in units with OEB 4 and 5 classifications. It has a long history in working with OEL levels going as low as 0.01 µg/m³.

10

Aspen API

Netherlands

TIDES USA

Booth #27, Level 2

Aspen API. More than just an API™

Pharma Service : API Manufacturing

HIGHLY POTENT API MANUFACTURING

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

11

Evonik

Germany

The Battery Show Europe

Evonik is the world’s largest contract manufacturing organization with more than 20 years of expertise in high-potency APIs. It has a total HPAPI capacity of 170m³, with reactors up to 7,600 liters in capacity.

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Pharma Service : API Manufacturing

CMO FOR HIGH POTENCY APIs (HPAPIs)

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

12

Fermion Oy

Finland

HPAPI CONTRACT MANUFACTURING SERVICES

Booth #719

With Fermion, start the journey of your innovative API.

Pharma Service : API Manufacturing

Fermion is a CDMO with manufacturing expertise in highly potent APIs, high-quality cytotoxics with three fully automated HPAPI modules for OEB5 (0,1 - 1 µg/m3) classified APIs with reactors of 250 L, 400 L and 600 L.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

13

Cohance Lifesciences

India

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Pharma Service : API Manufacturing

Cohance Lifesciences has state-of-the-art contract manufacturing facilities for the high potency APIs. It is a CDMO that can handle the development and production of HPAPIs including cytotoxic and oncology APIs with OEB 5 classification.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

14

Malladi Drugs & Pharmaceuticals Limited

India

Malladi has specialized facilities and systems for high potency active pharmaceutical ingredients (HPAPIs). Its facilities can support manufacturing volumes ranging from a kilo to multi-ton levels.

Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

Pharma Service : API Manufacturing

HPAPI MANUFACTURING SERVICES

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

15

Aarti Pharmalabs

India

STLE Annual Meeting

Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

Pharma Service : API Manufacturing

Aarti Pharmalabs is a leading CDMO that offers contract development and manufacturing (CDMO) services for various drug substances such as high-potency active pharmaceutical ingredients (HPAPIs), including anti-cancer and cytotoxic compounds.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

16

Ami Lifesciences Private Limited

India

CONTRACT MANUFACTURING FOR HIGH POTENCY ...

AMI Lifesciences is Driven by Chemistry. Powered by People.

Pharma Service : API Manufacturing

Ami Lifesciences is involved in the contract development and manufacturing of high potency APIs. It offers end-to-end services from small-scale to commercial manufacturing of HPAPIs and small molecules.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

Contract Manufacturing for High Potency APIs

17

Aurigene Pharmaceutical Services

India

Aurigene Pharmaceutical Services is a CDMO that provides highly potent API manufacturing services. It has cGMP isolator systems that can handle the manufacturing of HPAPIs, highly potent raw materials & intermediates in the range of 0.1-1 μg/m3 (OEB 5).

Aurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.

Pharma Service : API Manufacturing

HPAPI MANUFACTURING SERVICES

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

18

Pfizer CentreOne

U.S.A

CONTRACT MANUFACTURING FOR LIQUID CYTOTO...

Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.

Pharma Service : API Manufacturing

Pfizer offers contract manufacturing expertise for potent drugs, liquid cytotoxics, biologics, small molecules, controlled substances (II-IV), liposomal, inactivated vaccines, monobactam, hormones, steroids & prostaglandins.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

Contract Manufacturing for Liquid Cytotoxics

19

Farmhispania

Spain

Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.

Pharma Service : API Manufacturing

Farmhispania is a leading European contract development and manufacturing organization (CDMO) for high potency APIs. It offers cGMP manufacturing of HPAPIs including cytotoxics with an OEL below 30 ng/m3, from a few small grams to multi kilograms.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

20

Porton Pharma Solutions

China

Porton Pharma is a contract development and manufacturing organization (CDMO) that has a high potency lab (<0.05 ug/m³) for handling the production of highly potent APIs.

Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.

Pharma Service : API Manufacturing

HIGHLY POTENT API MANUFACTURING

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

21

Pfanstiehl

U.S.A

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

Pharma Service : API Manufacturing

Pfanstiehl is a CDMO that is involved in the development and manufacturing of HPAPIs. It is equipped with large-scale high potency manufacturing with class 100,000 / SafeBridge Category 1-3 production facility with an OEL range from 0.03 to 5 μg/m³.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

22

Bioquim

Spain

MANUFACTURING OF HIGHLY POTENT APIs (HPA...

Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.

Pharma Service : API Manufacturing

With expertise in sterile lyophilization and chemical synthesis, Bioquim CDMO offers the production of a wide range of cGMP oral and sterile APIs including high potency APIs (HPAPIs) for human and veterinary markets.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

Manufacturing of Highly Potent APIs (HPAPIs)